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The latest Biotech News and Views |
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| Let's navigate the change towards non-animal testing methods together! Learn more. |
Good morning! The FDA has just approved the first AI tool to help drug developers read liver biopsy images in clinical trials for MASH (metabolic dysfunction-associated steatohepatitis). The tool, developed by PathAI, uses algorithms to score key biopsy features like fat buildup, inflammation, and scarring, with a pathologist still reviewing and signing off on the results. The agency says that the AI lines up with expert scoring about as well as individual pathologists do, and while it's not cleared as a standalone diagnostic, it could make MASH trials faster and more consistent by reducing variability and bottlenecks. AI: now also available in "please grade my biopsy" mode.
Enjoy today's read!
- Joachim E. |
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| SNAPSHOT |
| Chinese biotech D3 Bio lands $108M to advance KRAS cancer drug into phase 3 |
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| D3 Bio secured $108M in Series B funding to launch global phase 3 trials of its lead KRAS G12C inhibitor, elisrasib, for solid tumors. |
| Why it matters: KRAS mutations are among the most common drivers of cancer. Advancing a next-gen inhibitor into late-stage trials could offer a new option for patients who don't respond to first-generation treatments. |
| Backstory: D3 Bio was launched in 2020 by AstraZeneca and BeiGene veteran Dr. George Chen with $200M in seed funding. The company focuses on precision oncology and immuno-oncology, targeting unmet needs using biomarker-driven approaches. |
| Big picture: The race to develop effective KRAS G12C therapies is heating up, with D3 Bio positioning elisrasib as a monotherapy and combo treatment for global regulatory approval. |
| Zoom in: Elisrasib targets KRAS G12C mutations, which are common in colorectal and non-small cell lung cancers (NSCLC). The drug showed "promising anti-tumor activity and favorable tolerability" in phase 1/2 trials in patients with advanced NSCLC resistant to existing KRAS treatments. The phase 3 trials will span the U.S., EU, and China and include combinations with Merck KGaA's monoclonal antibody Erbitux or checkpoint inhibitors. |
| What's next: D3 Bio will initiate global phase 3 trials of elisrasib and is also advancing a pipeline of immuno-oncology assets, including ERK inhibitors and bispecific antibodies. |
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| PRESENTED BY CN Bio |
| Ready to transform preclinical testing with Organ-on-a-chip? |
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With global regulations moving towards phasing out animal testing in favour of new approach methodologies (NAMs) and widening awareness that Organ-on-a-chip outperforms traditional in vitro approaches, there's no doubt the technology will become integral to drug discovery and development.
So, is it time to modernize your workflows? In this article, CN Bio outlines the key criteria for selecting the right solution—helping you onboard smoothly and realize benefits faster. |
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| SNIPPETS |
| What's happening in biotech today? |
| AI aspirations: PsiThera, a spinout from Roivant Sciences, has raised $47.5 million in a Series A funding round to develop oral small-molecule drugs targeting tumor necrosis factor (TNF) for immune-related conditions. Leveraging a proprietary AI platform, PsiThera aims to replicate the efficacy of injectable biologics like Humira and Enbrel in pill form, potentially offering more accessible and cost-effective treatments. Backed by investors including Lightstone Ventures and Samsara BioCapital, PsiThera expects to name its lead drug candidate in 2026. |
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| EGFR smackdown: BlossomHill Therapeutics has raised $84 million in a Series B extension to accelerate development of its clinical-stage oncology pipeline, bringing total funding to $257 million. The financing will support the advancement of BH-30643, a first-in-class, CNS-active, macrocyclic OMNI-EGFRTM inhibitor for EGFR-mutant non-small cell lung cancer (NSCLC), and BH-30236, a novel macrocyclic CLK inhibitor targeting aberrant RNA splicing in relapsed or refractory AML and high-risk MDS. Preliminary trial data for BH-30643 shows activity against complex EGFR resistance mutations, while BH-30236 has entered combination testing with venetoclax. Clinical updates for both programs are expected in 2026, with strong backing from institutional investors. |
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| SNAP AGAIN |
| Formation Bio launches Bleecker Bio with $605M Lynk immunology deal |
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| Formation Bio has launched a new subsidiary, Bleecker Bio, and signed a licensing deal with Lynk Pharmaceuticals worth up to $605 million to develop a next-gen central nervous system (CNS)-penetrant TYK2 inhibitor for autoimmune and inflammatory diseases. |
| Why it matters: The deal expands Formation's immunology portfolio and showcases its AI-driven drug development strategy, while giving Lynk a path to global exposure and revenue beyond China. |
| Backstory: Formation Bio, known for in-licensing or acquiring all of its drug candidates and then using AI to speed up drug development, raised $372M in 2024 and secured a $626M deal with Sanofi earlier in 2025. Lynk recently received FDA clearance for human trials of its TYK2 candidate. |
| Big picture: This partnership signals increasing biotech momentum toward AI-enhanced drug development and global collaboration, especially between Western and Chinese biotechs. |
| Zoom in: The asset, LNK01006, is an allosteric TYK2 inhibitor designed to target CNS immune pathways. Bleecker Bio gets global rights to LNK01006, excluding greater China. Lynk gains a minority stake in Bleecker, upfront cash, milestones, and royalties. |
| What's next: Formation Bio will initiate first-in-human trials for LNK01006 in the first half of 2026 under Bleecker Bio. |
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| TOUR OPERATOR |
| Upcoming events |
| San Francisco, 10 January 2026 – Sachs Annual Oncology Innovation Forum |
| London, 19 January 2026 – Bioseed |
| Heidelberg, 4 February 2026 – Life, the biomedical convention |
| Dubai, 9-12 February 2026 – WHX Dubai |
| Göttingen, 19 February 2026 – Life Science Start-up Day |
| London, 24-25 February 2026 – World ADC London 2026 |
| Amsterdam, 3-4 March 2026 – BioCapital |
| Barcelona, 10-12 March 2026 – Bioprocessing Summit Europe |
| Utrecht, 26 March 2026 – Innovation for Health |
| Vienna, 27-30 March 2026 – BioProcess International |
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| Disclaimer: The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical or AZoNetwork. |
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